US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 28, 2021 (5 years ago)

Sodium Chloride 0.9%

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Temperature Abuse: Product exposed to temperature outside specified limits.

What was recalled

Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10

Recalling firm
Fresenius Medical Care Holdings, Inc.
NDC code
46163-0300-10
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0603-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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